Ultrasonic cutting device

ABSTRACT

An ultrasonic surgical cutting method and apparatus is provided wherein the method and apparatus allows for the cutting of bone from within a hollow pathway such that a cutter associated with the ultrasonic method and apparatus remains sufficiently cool to prevent necrosis of the bone being cut. Furthermore the ultrasonic device and method can be employed in the cutting of soft tissue, wherein a cooled cutter is used to prevent the sticking of soft tissue to the cutting blade of the device during use.

RELATED APPLICATIONS

The present invention relates to U.S. patent application Ser. No. ______(Attorney Docket No. DUQ008A) entitled “Ultrasonic Cutting Device”,filed on Feb. 2, 2005.

FIELD OF THE INVENTION

The present invention relates to an ultrasonic cutting device, and moreparticularly to a system and method for cutting bone using an ultrasoniccutting device while preventing heat damage to the bone and neighboringtissue.

BACKGROUND OF THE INVENTION

The use of ultrasonic medical devices in surgery is widely known invarious surgical fields. Traditional surgical instruments usingultrasonic frequencies typically use the ultrasonic energy to dissect,coagulate, and cut living tissue during surgery. Existing ultrasonicsurgical devices typically employ an ultrasonic transducer to translateelectrical energy provided to the transducer into mechanical energy foruse in the intended surgical procedure. The mechanical vibratory motionis typically delivered to a distal end of the surgical instrument wherea cutter is located. Due to the mechanical vibratory motion, heat isgenerated at the cutter. In traditional medical procedures this heat isa sought after byproduct of the ultrasonic mechanical energy deliveredto the cutter, as the heat aids in the coagulation of tissue that is cutby the surgical instrument.

The heated output of traditional ultrasonic surgical devices, however,does introduce several inherent problems when used in various forms ofsurgery. If these devices are used to attempt to cut bone, for example,the high concentrated heat and mechanical vibration can result in thetemporary or permanent loss of blood supply to the region of bone incontact with the surgical device. This loss of blood supply in the boneis associated with necrosis of the bone, wherein bone tissue dies. Suchdeath of bone tissue is not clinically desirable. In light of this, theuse of ultrasonic cutting techniques with dense materials such as boneis not practical and is generally avoided. When faced with a need to cutbone, traditional invasive procedures are generally used. These invasiveprocedures generally require a larger incision and expose a patient to agreater risk of injury or infection. Furthermore, traditional mechanicalmeans used to cut bone often employ vibrating or rotating instruments.Such instruments may not differentiate between bone and surrounding softtissue, therefore the potential remains for unintentional damage to thesurrounding soft tissue which may result in permanent injury to apatient.

Furthermore, existing bone cutting surgical devices use a combination oflow frequency, located outside of the ultrasonic range, and lowamplitude levels to slowly cut through bone. With such an approach,however a long period of time is required to cut through a region ofbone. During a surgical procedure where the patient is under the effectsof aesthesia, a surgeon generally wishes to minimize the time that theprocedure takes to perform. While increasing the frequency or amplitudeof a bone cutting device would decrease the time required to cut throughthe bone, such an increase of frequency or amplitude results inexcessive heat generation at the cutter and the problems discussedabove. Additionally, the high heat of the device results incauterization of soft tissue which may result in irreversible damage toa patient.

SUMMARY OF INVENTION

In light of the inherent problems and concerns of existing surgicalcutting techniques, a cooling mechanism attached to the cutter of anultrasonic surgical device is beneficial. When the ultrasonic device isused to cut bone, reduction of heat at the cutter prevents bonenecrosis. Additionally, as the cutter is operating at a less elevatedtemperature, damage to tissue surrounding the cutter is less of aconcern. In light of this, should a cooled ultrasonic cutter stray fromthe intended subject and accidentally come into contact or close contactwith an unintended region of tissue, the likelihood of damage to thistissue is reduced.

The present invention relates to surgical cutting devices whereinultrasonic vibration can be used in conjunction with a coolingmechanism. Using a cutting and cooling arrangement, as provided in thepresent invention, a cooled cutter can be used in cutting hard tissuessuch as bone, and is further capable of preventing heat related damageto hard or soft tissue surrounding the site of intended use.

Providing an ultrasonic cutting device wherein the cutter is maintainedat a reduced temperature offers numerous advantages as compared toexisting surgical devices. Firstly, the combination of ultrasoniccutting frequencies provides for speedy removal of bone during asurgical procedure. Additionally, as the cutting tip is at a reducedoperating temperature, traditional problems with bone necrosis due toheat are reduced. In light of this, damage to the region of hard or softtissue surrounding the location of the cut are minimized.

Additionally, the inherent concerns of a surgeon when using a high-heatultrasonic cutting device in close proximity to hard or soft tissue thatis not being cut are further eliminated by a ultrasonic surgical devicethat maintains a reduced cutter temperature. For example, extensivenecrosis to cortical bone has been reported at temperatures of 70° C.The temperature threshold where tissue damage occurs has been found tobe 56° C. Some studies have correlated thermal damage to tissue to themagnitude of temperature and the period of time during which the tissueis subjected to damaging temperatures. This thermal damage has beenshown to effect bone reformation. Heating bone to 47° C. or 50° C. for 1minute can cause significantly reduced bone reformation. Furthermore,nervous tissue is particularly sensitive to elevated temperatures andmay become damaged at temperature at 42° C. In light of this, thepresent invention provides a reduced heat cutting tip such that damageto hard of soft tissue in the region to be cut is prevented.

In one embodiment of the present invention, during a surgical procedurewhere bone is to be cut, should a surgeon accidentally stray from theintended target bone and come into contact with surrounding nervoustissue, a reduced temperature ultrasonic cutting device is less likelyto cause damage to the nervous tissue. In light of this, unintendednerve damage and paralysis is subsequently avoided while using a reducedtemperature ultrasonic cutting device.

The present invention can additionally perform lateral cuttingoperations. For example, using the present invention, a surgeon canlaterally cut a region of bone from within a predefined hollow providedin the bone. For example, when used during spinal surgery, the presentinvention offers a surgeon the benefit of a compact ultrasonic devicethat can be readily guided down a predefined hollow pathway to a fixeddepth. In one such surgical procedure, namely a stenosis correctionprocedure, the pedicles of a vertebrae are cut at corresponding pointssuch that the pedicle can be separated from the main portion of thevertebral segment. Such a procedure is defined in U.S. PatentApplication No. US 2003/0212400 to Bloemer, and U.S. Pat. No. 6,358,254B1 to Anderson, both of which are herein incorporated by reference. Inaccordance with the Bloemer application and Anderson patent, a hollowpathway is provided in the pedicle region of a vertebra. This hollowpathway can be generated using existing drilling techniques. Followingthe drilling of a hollow pathway, a need exists to cut through thematerial of the pedicle region such that an expandable screw may beplaced within the hollow pathway. The required cutting, if completedfrom within the predefined hollow region, must be lateral in nature. Thepresent invention, and its lateral cutting aspects, allows for thepredefined hollow in the bone to be used to properly orient the surgicalinstrument. This expandable screw, placed in the now severed pedicle,allows for the separation of the pedicle from the main portion of thevertebrae such that stenosis is eliminated.

Using the present invention, the pedicle region can be carefully cut atfixed locations in a lateral manner such that the expandable screw canlater be implanted and expand. Such an arrangement eliminates thepotential for error in cutting a region of a vertebra, as the predefinedhollow is used to orient the cutter, and further provides a readilyrepeatable cut along various regions of a vertebra. Additionally, thepresent ultrasonic cutter is easily operable by a surgeon, requiringonly a simple insertion and revolution of a hand piece assembly. Inlight of this, when used in conjunction with a predefined hollowpathway, spinal surgery can be performed in a minimally invasive mannersuch that repeatable results can be obtained without unintended damageto surrounding soft tissue. As the surgical procedure can be lessinvasive than traditional techniques, unnecessary trauma to a patient isprevented and the potential for infection is greatly reduced.

Additionally, when the device is employed using a high amplitude signal,soft tissue can be cut. As the present invention includes a cooledcutter, the cooled cutter arrangement is such that soft tissue cut bythe present invention does not unnecessarily stick to the cutter.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become better understood with reference tothe following description and accompanying drawings, wherein:

FIG. 1 is a is an illustrative graphical embodiment of a system for usewith the present invention in accordance with one aspect of the presentinvention.

FIG. 2A is an illustrative embodiment of the present invention in astate where the cutter is retracted while located in a predefinedhollow.

FIG. 2B is an illustrative embodiment of the present invention in astate where the cutter is extended while located in a predefined hollow.

FIG. 2C is a detailed view of an illustrative embodiment of a portion ofthe system, wherein the internal workings of the rotatable hand pieceare detailed.

FIG. 3A is a flowchart illustrating the steps required in spinalstenosis correction when the pedicle region of a vertebrae is cut.

FIG. 3B is an illustrative graphical embodiment of the present inventionwhen used in stenosis correction surgery within a vertebrae of apatient.

FIG. 4 is a cutaway view of the lateral cutter of the present inventionwhen disposed upon a hollow vibratory shaft for use in convectivecooling of the lateral cutter.

DETAILED DESCRIPTION

The present invention generally relates to an ultrasonic surgicalcutting system, wherein a lateral cutter is used to cut through hardtissue such as bone, while simultaneously preventing unintended damageto tissue adjacent to the intended tissue to be cut. Additionally, thepresent invention provides for cutting of an intended material using alateral cutter, wherein the lateral cutter has a reduced temperature.Because the device employs a cooled cutter arrangement, inherentproblems of ultrasonic cutting instruments are reduced. For example,using a cooled cutter arrangement coupled with a low initial amplitude,bone may be cut in a manner such that necrosis does not develop.Additionally, while cutting a hard tissue such as bone, should thecooled cutter contact surrounding soft tissue, damage to the soft tissuewill not result. Furthermore, coupled with an increase in amplitude tocut soft tissue, the cutter's temperature is reduced so that soft tissuecut by the present invention does not unnecessarily stick to the cutter.

FIG. 1 is a is an illustrative graphical embodiment of a system for usewith the present invention in accordance with one aspect of the presentinvention. The present system includes an ultrasonic generator 100capable of producing an ultrasonic frequency. The generator's frequencyis in the range of about 22 Khz to 45 Khz and contains a variableamplitude component. For example, a low amplitude can be employed whilecutting a hard tissue such as bone, and a higher amplitude can beemployed when the intended tissue to be cut is soft. Associated with thegenerator 100 is an ultrasonic transducer 104. The ultrasonic transducerallows for the conversion of electrical energy supplied by theultrasonic generator 100 into mechanical energy which can be transmittedto a vibratory shaft 112 associated with the transducer 104. Thetransfer of energy between the ultrasonic generator 100 and thetransducer 104 occurs using a electrical pathway 102. The electricalpathway can be a electrical connector between signal generator 100 andtransducer 104 such that electrical energy can be delivered to thetransducer 104. In the alternative, the electrical pathway 102 can beeliminated and the remotely located ultrasonic generator 100 can beintegrated directly into the surgical cutting system. The couplingbetween the transducer 104 and the vibratory shaft 112 is such thatmechanical motion generated by the transducer 104 is transferreddirectly to the vibratory shaft 112. The vibratory shaft 112 istherefore sized and constructed of an appropriate material tosufficiently transmit the mechanical motion of the transducer 104without unnecessary attenuation of the ultrasonic signal. For example,surgical grade stainless steel or titanium may be used in constructionof the vibratory shaft 112. The ultrasonic generator 100, transducer 104and electrical pathway 102 may take numerous forms as understood by oneskilled in the art. For example, existing commercially availablesurgical instruments including the aforementioned elements may be usedin practicing the present invention. Furthermore, the need for thevibratory shaft 112 may be reduced or eliminated based upon shape andorientation of the transducer 104 employed.

The vibratory shaft 112 is contained within a guide tube 108. The guidetube 108 is sized such that the guide tube 108 can be readily placeddown a predefined hollow pathway (not shown) such that the hollowpathway serves to orient the guide tube 108 and associated ultrasonicsurgical cutting system. Furthermore the guide tube serves to containthe vibratory shaft 112 such that the vibratory shaft does not come incontact with surrounding tissue or bone. The predefined hollow pathwaycan be readily provided using existing techniques such as drilling. Forexample, during use in stenosis correction surgery, a hollow pathway canbe provided in each pedicle of a vertebra such that upon cutting thepedicle an anterior and posterior region is formed. Using a mechanicalmeans, these anterior and posterior regions may be separated such thatnervous tissue compression within the vertebrae is eliminated.

Associated with the distal end of the vibratory shaft 112 is a cutter114. In the present embodiment, the cutter illustrated is a lateralcutter located perpendicular to the vibratory shaft 112. One skilled inthe art, however, will readily recognize that the cutter may be placedat a variety of angles in relation to the vibrator shaft 112 such thatthe circumferential cut traced by the cutter 114 is at the requiredangle specific to the surgical procedure to be performed. The cutter 144is sized and oriented such that while in the stored position thefootprint of the cutter remains within the region defied by the guidetube. The cutter can be formed of any biocompatible material such astitanium or surgical grade stainless steel, and may be of variousthicknesses. In one embodiment of the present invention, when used instenosis correction the cutter is in the range of 2 to 3 millimetersthick. One skilled in the art will readily recognize, however, that thecutter thickness can be readily varied based upon the surgical needs ofthe intended procedure. The guide tube may be inserted into the hollowpathway such that the cutter 114 does not contact the walls of thehollow pathway during insertion. For illustrative purposes, the cutter114 is shown as permanently affixed to the vibratory shaft 112. Oneskilled in the art will readily recognize that the cutter 114 may beaffixed to the vibratory shaft 112 using various arrangements such asmechanical fastening means like screws. In the alternative, the distalend of the vibratory shaft 112 may contain a threaded section, such thatan intended cutter 114 can simply be threaded onto the ultrasoniccutting system based upon the pending surgical procedure. Using such anarrangement, a surgeon can use the present invention during a pluralityof surgical procedures which require specialized cutters 114 for use inthe cutting of bone.

In conjunction with the insertion of the guide tube 108 into the hollowpathway, an adjustable stop 110 located on the guide tube 108 can beutilized in defining the depth of penetration of the guide tube 108within the hollow pathway. The adjustable stop 110 can be preconfiguredby a surgeon prior to insertion of the guide tube 108 into a hollowpathway. In one embodiment of the present invention, a set ofcalibration markings can be located along the length of the guide tube108 such that a distance from cutter 114 to adjustable stop 110 can beeasily set. In light of this, repeatable cuts at a fixed depth can bereadily performed. When used in connection with stenosis correctionsurgery, for example, the depth of cut in both regions of the pediclecan be easily maintained using the adjustable stop 110. The adjustablestop 110 can be fixed using several means as understood by one skilledin the art. For example, a simple set screw arrangement can be employedwherein a surgeon can use a supplied tool to lock the adjustable stop inplace on the guide tube 108. In the alternative, the adjustable stop 110can simply be retained along the length of the guide tube 108 using afriction fit.

The vibratory shaft 112 of the present invention is located in an offsetmanner to the centerline of the guide tube 108 such that the cutter 114is located within the periphery of the guide tube while stored in theretracted portion. FIG. 2A illustrates a retracted view of the cutter114 prior to deployment of the cutter. FIG. 2A further illustrates theeccentrically mounted vibratory shaft 112 located on an eccentric axis152 of the present invention in relation to the longitudinally axis 150of the guide tube 108. The eccentrically mounted vibratory shaft 112allows for the deployment of the cutter to a deployed position, asillustrated in FIG. 2B, upon rotation of the vibratory shaft 112. Uponextension of the cutter 114, as illustrated in FIG. 2B, the ultrasonicsurgical cutting system can be rotated about the central axis of theguide tube such that the cutter 114 provides a circumferential groove inthe surrounding bone 120.

The cutter 114 of the present invention can be deployed into an extendedposition via operation of a rotatable hand piece 116. In one embodiment,the rotatable hand piece 116 includes a geared mechanism incommunication with the vibratory shaft 112 such that upon rotation ofthe rotatable hand piece 116 the cutter 114 is rotated along aneccentric axis 152 located parallel to the guide tube 108. Upon rotationof the vibratory shaft and the attached cutter 114, the cutter can bedeployed a variety of levels of extension beyond the exterior wall ofthe guide tube 108, such that the cutter can cut a variety of depths inthe surrounding bone or tissue. Following the deployment of the cutter114, the entire ultrasonic surgical cutting system can be rotated, usingthe supplied rotatable hand piece 116 such that the cutter sweepsthrough a circumferential path. The circumferential sweep of the cutter114 results in a circumferential cut in the surrounding bone or tissuewith a width of cut corresponding to the width of the cutter 114 and adepth of cut related to the depth of the extended cutter beyond theexterior of the guide tube 108.

Using such an arrangement, cuts of varying depths in the surroundingbone or tissue can be made using an incremental approach. An initialcutter depth can be set and the ultrasonic surgical cutting system canrevolved, thereby resulting in a first circumferential cut in thesurrounding bone or tissue. The cutter 114 depth can then be increased,and the cutter swept through a second revolution, thereby creating adepth increase as compared to the initial cut in the surrounding bone ortissue. Using such an approach, one skilled in the art will readilyrecognize that deep cuts in the surrounding bone or tissue can beperformed using a multi-pass arrangement such that cutter amplitude andfrequency can be kept to a minimum, as a minimal amount of material areremoved in each pass, thereby reducing heat buildup at the cutter 114.Such an arrangement offers the benefit of decreased potential fornecrosis development in surrounding bone, as the cutter tip ismaintained at a reduced temperature. In the alternative, one skilled inthe art will recognize that a full depth cut can be performed in asingle pass using the present invention in a situation where such a cutis surgically necessary and acceptable. In addition, in the alternative,the radius of the cut can be varied during the single pass toaccommodate the shape of the pedicle region. Due to the oblong shape ofthe pedicle cross-section, the desire to control the cutting depth isoptimal. As the axis of the vibratory shaft 112 is offset from the axisof the guide tube 108 the radius of the cut can be varied bysimultaneously manipulating the extent of cutter extension beyond theguide tub 108 and the rotation of the ultrasonic cutting device. Forexample, the cutter extension can be infinitely varied as the ultrasoniccutting instrument is rotated along the central axis of the guide tube108. Such an arrangement creates an infinite depth of cut up to themaximum extended length of the cutter 114.

When used in spinal stenosis correction surgery, for example, acircumferential cut originating from within a predefined hollow pathwayregion can be made at a fixed depth. This circumferential cut throughthe pedicle region can be made in a single pass using a fully deployedlateral cutter, or can be made in several circumferential passes duringwhich the cutter is deployed at an increasing depth along each pass. Asthe guide tube 108 is located within the predefined hollow pathway, theultrasonic surgical cutter relationship is maintained throughout thecutting procedure such that a uniform cut results. Additionally, as thecutting originates from within the predefined hollow region, the cuttingprocedure remains minimally invasive.

The ultrasonic generator 100 provided a signal containing both a knownamplitude and frequency. In one embodiment, a frequency of 22 kHz, andamplitude of 80 microns, can be utilized for ultrasonic cutting. Asunderstood by one skilled in the art, both amplitude and frequency canbe varied based upon the specific use of the ultrasonic surgical cuttingsystem. For example, when used to cut bone, a low amplitude of thegenerated signal can be maintained such that excessive heating does notoccur at cutter 114. Excessive heating at the cutter 144, when used incutting bone, can result in bone necrosis. Additionally, using a lowamplitude will reduce the likelihood of cutting soft tissue in which thecutter may come in contract once the outer edge of bone is reached.Employing a low amplitude signal therefore reduced excessive tip heatingand the onset of necrosis. In the alternative, when the presentultrasonic surgical cutting system is employed to cut through softtissue, the amplitude of the supplied signal can be increased such thatthe performance of the present invention when used to cut soft tissue isincreased. For example, an increase in the speed of the blade, asgoverned by increases in the associated amplitude and frequency, offersincreased ability to cut through soft tissue such as bone, while thecutter temperature remains reduced due to the cooling mechanismassociated with the cutter. Employing a higher amplitude results inincreased cutter 114 temperature, which serves to cauterize the regioncut by the ultrasonic surgical cutting system, thereby preventing bloodloss.

FIG. 2C of the present invention is an illustrative cutaway example ofthe rotatable hand piece assembly 116 of the present invention. Therotatable hand piece assembly 116 performs the dual function of bothextending the cutter 114 of FIG. 2B to a predetermined depth of cutbeyond the confines of the external surface of the guide tube 108, aswell as allowing a surgeon to rotate the entire ultrasonic surgicalcutter system, such that the cutter 114 of FIG. 2B sweeps through anintended range of motion. The movement of the cutter 114 of FIG. 2Bthereby creates a circumferential groove in the surrounding bone ortissue in contact with the cutter. For illustrative purposes, cutter isherein described in relation to a full circular sweep, yet one skilledin the art will readily recognize that the cutter can be swept throughan isolated range of motion. In light of this, detailed removal ofregions of bone can be effectuated using the present invention. Asillustrated in FIG. 2C, the transducer 104 and associated vibratoryshaft 112 are located in an offset manner in relation to the centerline150 of the rotatable hand piece 16 and guide tube 108 such that thecutter 114 of FIG. 2B maintains an eccentric range of motion when movedfrom the retracted position within the guide tube to the extendedposition. Furthermore, in the illustrative embodiment, the rotatablehand piece 116 includes a geared mechanism for deploying the cutter fromthe stowed position. As illustrated in the present embodiment the gearedmechanism 200 includes a ring gear 210 associated with the rotatablehand piece. This ring gear, upon rotation of the rotatable hand piece,provides for transmission of rotational energy to an intermediate spurgear 212. The intermediate spur gear 212 further transfer the initialrotation of the rotatable hand piece 116 to a pinion gear 214 associatedwith the vibratory shaft. Such a transfer of rotational energy resultsin the rotation of the vibratory shaft 112 and the subsequent deploymentof the attached cutter 114. One skilled in the art will readilyrecognize that the sizing and tooth count of the illustrated gears canbe sized and specified such that the requisite mechanical advantage androtational speeds are provided in accordance with the needs of thepresent invention.

The geared mechanism 200 of the present embodiment is used solely forillustrative purpose. One skilled in the art will readily recognize thatthe geared mechanism 200 may be replaced by numerous alternativemechanisms capable of extending the cutter 114. For example, a rack andpinion arrangement can be utilized in place of the circular gear trainof the present embodiment. In the alternative, a planetary geararrangement can be utilized for use in extending the cutter 114 andproviding for a means by which the ultrasonic surgical cutting systemcan be rotated along the longitudinal axis of the guide tube 108.

Furthermore, upon deploying the cutter 114 of FIG. 2B, the rotatablehand piece 116 is further rotated such that the entire ultrasonicsurgical cutting system is rotated about the longitudinal axis (notshown) of the guide tube 108. Rotation of the ultrasonic surgicalcutting system, and eccentric mounted vibratory shaft 112 and attachedcutter 114, results in the removal of material from the surroundinghollow pathway 122. A full rotation of the rotatable hand piece 116thereby results in a circular groove in the material surrounding thehollow pathway 122. Additionally, the cutter 114 depth can be graduallyadvanced such that that a deepening circular groove can be tracedfollowing several rotations of the rotatable hand piece 116.

FIG. 3A is a flowchart illustrating the steps necessary in using thepresent invention to correct stenosis by cutting a pedicle region of avertebrae. In accordance with step 300 a hollow pathway is initiallyprovided in a pedicle region of the vertebrae to be cut. This hollowpathway can be provided using numerous existing techniques, asunderstood by one skilled din the art. For example, a drilling mechanismcan be used such that a circular hole is bored into the intended regionto be cut. In accordance with step 302, a lateral ultrasonic cutter isoriented within the hollow pathway at a fixed distance such that thecutter is appropriately located for cutting of the pedicle region of avertebrae. The lateral ultrasonic cutter is then extended (304) beyondthe hollow region of the hollow pathway and into the surrounding bone ofthe vertebrae. Following the extension of the lateral ultrasonic cutter,the cutter is rotated in a circumferential manner such that acircumferential groove is cut within the surrounding bone of the hollowpathway. (step 306) The ultrasonic lateral cutter may cut through thepedicle region in a single pass, or the depth of cut may beincrementally increased such that the ultrasonic lateral cutter cutsthrough the pedicle region in multiple revolutions.

FIG. 3B illustrates an embodiment of the present invention when used instenosis correction in a lower vertebrae of a human patient. The lowervertebra is provided with a hollow pathway 122 which can be drilledusing existing bone drilling techniques. Following the provision of thehollow pathway, the guide tube, and associated cutter 114 can beinserted into the hollow pathway 122 using the surrounding bone 120 as aguide to locate the guide tube 108 against. The guide tube 108 can bedeployed to a fixed distance either manually, or can be placed withinthe hollow pathway 122 until the adjustable stop 110 comes in contactwith the upper region of the hollow pathway 122. Following insertion ofthe guide tube within the hollow pathway 122, the presently retractedcutter 114 can be deployed upon rotation of the eccentrically mountedvibratory shaft 112. Rotation of the vibratory shaft 112 occursfollowing rotation of the hand piece assembly 116 of FIG. 2C. Due to theeccentric location of the vibratory shaft 112, when viewed relative tothe guide tube 108 centerline, the cutter 114 is deployed in a mannerwhere the cutter extends beyond the confines of the guide tube 108.Using such an arrangement, the cutter, which is receiving an ultrasonicvibration comprising an amplitude and frequency, can be rotated in acircumferential manner, thereby producing a groove in the surroundingbone 120. One skilled in the art will readily recognize that the presentcutter 114 is oriented perpendicular to the vibratory shaft 112 but anynumber of relative angles between cutter 114 and vibratory shaft 112 canbe employed.

FIG. 4 of the present invention illustrated the use of a convectivecooling mechanism for use with the present invention. The convectivecooling pathway 400 is located internal to the vibratory shaft 112 andextend along the vibratory shaft 112 for a sufficient distance toadequately cool the cutter 114 associated with the vibratory shaft 112.As the cutter 114 of the present invention is in thermal contact withthe vibratory shaft 112 of the present embodiment, heat generated in thecutter during operation is passed to the vibratory shaft throughconduction. Heat passed to the distal end of the vibratory shaftadjacent to the cutter 114 is then passed to the convective coolingpathway 400 located internal to the vibratory shaft 112. Within theconvective cooling pathway 400 a thermal gradient is established suchthat a working fluid is circulate along the thermal gradient from thecutter region 114 to the opposing end of the convective cooling pathway.

In one embodiment the convective cooling pathway includes a cellularmatrix arrangement disposed within the convective cooling pathway 400.Existing conductive cooling pathways for use in surgical forceps arerecognizable by one skilled in the art. One such example of convectivecooling pathways is exhibited in the IsoCool™ Bipolar Forceps, hereinincorporated by reference, offered by Codman, a Johnson & JohnsonCompany. The cellular matrix has a hollow central region parallel to thecenterline of the vibratory shaft 112 such that a heated working fluidmay travel up the hollow central region. In operation, the working fluidis instantly evaporated at the interface between vibratory shaft 112 andcutter 114. This now gaseous working fluid travels up the hollow centralregion of the convective cooling pathway 400 wherein it slowly cools asif moves further from the heated vibratory shaft 112 cutter 114interface. The working fluid may then return to the interface 402 bypassing through the cellular matrix of the convective cooling pathway.In one embodiment the cellular matrix may be made of a copper compound.In the present embodiment, the movement of the working fluid within theconvective cooling pathway 400 is driven by the associated thermalgradient provided between the heated interface 402 region and the coolopposing end of the conductive cooling pathway 400. Those skilled in theart will readily recognize that the described cellular matrixarrangement is solely used for illustrative purposes and may besubstituted by numerous convective cooling mechanisms as understood byone skilled in the art.

The use of the convective cooling pathway 400 with the present inventionallows for the cooling of the cutter 114 such that heat generated at thecutter during use is partially or fully removed. In light of this, thecooled cutter 114 therefore reduces inherent problems with bone necrosisor inadvertent damage to soft tissue in regions surrounding the cutter114. Furthermore, should the present invention be used in the cutting ofsoft tissue, the use of a cooled cutter prevents the inherent problemswith tissue sticking to the cutter due to the high temperatureassociated with existing cutters.

FIGS. 1 through 4, wherein like parts are designated by like referencenumerals throughout, illustrate an example embodiment of an ultrasoniccutting device according to the present invention. Although the presentinvention will be described with reference to the example embodimentsillustrated in the figures, it should be understood that manyalternative forms can embody the present invention. One of ordinaryskill in the art will additionally appreciate different ways to alterthe parameters of the embodiments disclosed, such as the size, shape, ortype of elements or materials, in a manner still in keeping with thespirit and scope of the present invention.

Numerous modifications and alternative embodiments of the presentinvention will be apparent to those skilled in the art in view of theforegoing description. Accordingly, this description is to be construedas illustrative only and is for the purpose of teaching those skilled inthe art the best mode for carrying out the present invention. Details ofthe structure may vary substantially without departing from the spiritof the present invention, and exclusive use of all modifications thatcome within the scope of the appended claims is reserved. It is intendedthat the present invention be limited only to the extent required by theappended claims and the applicable rules of law.

1) An ultrasonic surgical cutting system, said system comprising anultrasonic transducer element for producing an ultrasonic output: and anultrasonic lateral cutter associated with the ultrasonic transducerelement, wherein the lateral cutter can be oriented for use in surgicalcutting. 2) The system of claim 1, further comprising a ultrasonicgenerator, wherein said ultrasonic generator is capable of producing anultrasonic signal for use with the ultrasonic transducer. 3) The systemof claim 1, further comprising a rotatable handpiece, wherein thehandpiece is sized and oriented to contain the ultrasonic transducer. 4)The system of claim 1, further comprising a vibratory shaft, saidvibrator shaft sized and orientated to transmit a mechanical motionproduced by the ultrasonic transducer to the ultrasonic lateral cutter.5) The system of claim 1, wherein said transducer is capable oftransmitting an ultrasonic signal in the frequency range in betweenabout 22 Khz and about 45 Khz. 6) The system of claim 1, wherein saidtransducer is capable of transmitting an ultrasonic signal with anamplitude in the range between about 50 to about 100 microns. 7) Thesystem of claim 3, wherein the hand piece assembly further comprisesgears wherein upon rotation of the handpiece the vibratory shaft andassociated attached cutter is rotated such that a circumferentialpathway is traced by the lateral ultrasonic vibratory cutter. 8) Thesystem of claim 4, wherein the vibratory shaft is housed within a guidetube such that the ultrasonic lateral cutter associated with thevibratory shaft is eccentrically oriented to the guide tube. 9) Thesystem of claim 4, wherein the vibratory shaft further includes aconvective cooling pathway located internal to the vibratory shaft. 10)The system of claim 9, wherein the convective cooling pathway removesheat generated at the lateral cutter during surgical cutting operations.11) The system of claim 10, wherein the convective cooling pathwaymaintains a lateral cutter temperature less than approximately 50° C.12) The system of claim 10, wherein the convective cooling pathwaymaintains a lateral cutter temperature less than approximately 45° C.13) The system of claim 10, wherein the convective cooling pathwaymaintains a lateral cutter temperature less than approximately 40° C.14) The system of claim 8, wherein a adjustable stop is associated withthe guide tube, such that the adjustable stop may be oriented at aplurality of points along the length of the guide tube. 15) The systemof claim 8, wherein calibration markings are provided along the lengthof the guide tube for use in determining penetration depth of the guidetube in an associated cavity. 16) The system of claim 1, wherein saidsystem is capable of cutting bone using a predetermined amplitude andfrequency signal. 17) The system of claim 1, wherein the ultrasoniclateral cutter is made of a biocompatible material 18) The system ofclaim 4, wherein the ultrasonic later cutter is modular, such that aplurality of differently sized and oriented lateral cutters can beattached to the vibratory shaft 19) The system of claim 1, wherein theultrasonic lateral cutter is oriented perpendicular to the ultrasonictransducer. 20) The system of claim 1, wherein the ultrasonic lateralcutter is orientated at a plurality of angles relative to the ultrasonictransducer. 21) The system of claim 1, wherein the ultrasonic cuttertraces a variable radius depth of cut in the material surrounding thecutter. 22) The system of claim 1, wherein said system is used instenosis correction surgery. 23) A ultrasonic cutting device for use incutting bone having a cooled cutter, said device comprising: anultrasonic transducer for generating an ultrasonic output; a ultrasoniccutter associated with said ultrasonic transducer; and a convectivecooling mechanism associated with the ultrasonic cutter and ultrasonictransducer, wherein the convective cooling mechanism provides for acooled cutter in the ultrasonic cutting device. 24) The ultrasoniccutting device of claim 23, said device further comprising a ultrasonicgenerator capable of producing a signal with a frequency in the rangebetween about 22 Khz and about 45 Khz. 25) The ultrasonic cutting deviceof claim 23, said device further comprising a ultrasonic generatorcapable of producing a signal with an amplitude in the range betweenabout 50 to about 100 microns. 26) The ultrasonic cutting device ofclaim 23, wherein the convective cooling mechanism comprises a thermallyconductive cellular matrix disposed within the convective coolingmechanism 27) The ultrasonic cutting device of claim 23, wherein theconvective cooling mechanism includes a working fluid, wherein theworking fluid undergoes a fluid reflux within the convective coolingmechanism. 28) The ultrasonic cutting device of claim 23, wherein aconvective thermal gradient originating at the cutter and extendingtoward the ultrasonic transducer is establish within the convectivecooling mechanism. 29) The device of claim 26, wherein said thermallyconductive cellular matrix includes a hollow central region capable ofpassing a heated working fluid originating at the cutter end of theconvective cooling mechanism. 30) The device of claim 26, wherein acooled working fluid returns to the end of the convective coolingmechanism associated with the cutter via the cellular matrix of theconvective cooling mechanism.
 31. A tool for cutting tissue comprising:a mechanical cutting tip and a convection cooling system incorporatedwithin the tool to cool the mechanical cutting tip to a temperaturesufficient to inhibit tissue necrosis.
 32. The tool of claim 31, whereinthe mechanical cutting tip is a drill bit.
 33. The tool of claim 31,wherein the mechanical cutting tip is a burr.
 34. The tool of claim 31,wherein the mechanical cutting tip is a blade.
 35. The tool of claim 31,wherein the mechanical cutting tip is an ultrasonic cutting tip.
 36. Thetool of claim 32, further comprising a tool body having a proximal endand a distal end, wherein the convection cooling system is positionedwithin the tool body.
 37. The tool of claim 32, wherein the convectioncooling system comprises a thermally conductive cellular matrix, and aworking fluid.